WO2013077031A1 - Instrument d'extension - Google Patents

Instrument d'extension Download PDF

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Publication number
WO2013077031A1
WO2013077031A1 PCT/JP2012/069684 JP2012069684W WO2013077031A1 WO 2013077031 A1 WO2013077031 A1 WO 2013077031A1 JP 2012069684 W JP2012069684 W JP 2012069684W WO 2013077031 A1 WO2013077031 A1 WO 2013077031A1
Authority
WO
WIPO (PCT)
Prior art keywords
insertion member
vaginal
urethral
expansion device
cavity
Prior art date
Application number
PCT/JP2012/069684
Other languages
English (en)
Japanese (ja)
Inventor
有浦　茂樹
政克 川浦
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2013545816A priority Critical patent/JP6000975B2/ja
Priority to DE112012004850.4T priority patent/DE112012004850T5/de
Publication of WO2013077031A1 publication Critical patent/WO2013077031A1/fr
Priority to US14/283,834 priority patent/US9642636B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0206—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A61B2017/0225—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery flexible, e.g. fabrics, meshes, or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072—Delivery tools therefor

Definitions

  • the present invention relates to an expansion device.
  • Urinary incontinence particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc.
  • the cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
  • Surgical therapy is effective for the treatment of urinary incontinence.
  • a tape-like implant called “sling” is used, and the sling is placed in the body, and the urethra is supported by the sling (see, for example, Patent Document 1). ).
  • the operator incises the vagina with a scalpel, peels off the living tissue between the urethra and the vagina, and uses a puncture needle or the like to open a closed hole between the peeled living tissue and the outside. Communicate with each other. Then, in such a state, the sling is placed in the peeled biological tissue in the body.
  • the living tissue between the urethra and the vagina is a very thin layer, and depending on the skill of the operator, the urethra may be damaged during peeling of the living tissue. Further, when the release layer of the biological tissue is close to the vagina side, the placed sling may be too close to the vagina side. In this case, with the progress after the operation, the sling may break the vagina wall and be exposed in the vagina.
  • An object of the present invention is to provide an expansion device capable of easily and reliably performing a surgical procedure on a living tissue between a vaginal cavity and a urethral cavity.
  • an elongated vaginal insertion member inserted into the vaginal cavity among the vaginal cavity and urethral cavity adjacent to each other through a living tissue;
  • a longitudinal urethral insertion member inserted into the urethral cavity;
  • a connecting means for connecting the vaginal insertion member and the urethral insertion member so as to be close to and away from each other Provided on the vaginal insertion member, and provided with vaginal side regulation means for regulating the positional relationship of the vaginal insertion member inserted into the vaginal cavity with respect to the living tissue,
  • the vaginal insertion member is inserted into the vaginal cavity, the urethral insertion member is inserted into the urethral cavity, and the positional relationship is regulated by operation of the vaginal side regulating means, and the vaginal insertion member is inserted into the urethra
  • An expansion device configured to spread the living tissue in a separation direction by separating the insertion member from
  • the vaginal insertion member is constituted by a plate-shaped member
  • the vaginal side regulating means is formed by opening at an internal space formed inside the vaginal insertion member and a surface of the vaginal insertion member facing the urethral insertion member, and communicates with the internal space.
  • a suction port connected to a suction means for sucking the internal space, and when the suction means is operated in the connected state, the biological tissue is applied to the vaginal insertion member by a suction force generated at the suction port.
  • the expansion device according to the above (1), which pulls and regulates the positional relationship.
  • the vaginal side regulating means includes at least one clamping mechanism that clamps the living tissue, and pulls the living tissue to the vaginal insertion member by the clamping force of the clamping mechanism to regulate the positional relationship.
  • the expansion instrument as described in said (1).
  • the clamping mechanism includes a pair of clamping pieces that clamp the living tissue, and a biasing unit that biases each clamping piece in a direction in which the clamping force is generated or a direction in which the clamping force is released.
  • the expansion instrument as described in (6).
  • the coupling means includes a lock mechanism that temporarily maintains a constant distance between the vaginal insertion member and the vaginal insertion member.
  • the lock mechanism includes a bolt, and the distance is maintained constant by tightening the bolt, and the distance is variable by loosening the bolt.
  • the expansion device as described in.
  • the urethral insertion member is composed of a rod-shaped member,
  • the urethral side restricting means is formed by opening at a surface of the urethral insertion member facing the vaginal insertion member, and at least one communicating with the flow channel.
  • An auxiliary suction port connected to a suction means for sucking the inside of the flow path, and when the suction means is operated in the connected state, the biological tissue is transferred to the urethra by a suction force generated at the auxiliary suction port.
  • the expansion instrument according to (11) wherein the expansion instrument is pulled toward the insertion member to regulate a positional relationship of the urethral insertion member with respect to the living tissue.
  • the vaginal insertion member is constituted by a plate-shaped member, and has a window portion that allows the other surface side to be visually recognized from one surface side thereof. Expansion device.
  • the urethral side regulating means includes a balloon that can be expanded and contracted, and any one of the above (1) to (13) that regulates a longitudinal position of the urethral insertion member in a state where the balloon is expanded.
  • the expansion device as described in.
  • the urethral insertion member has a deformed portion that is partially deformed, and when the deformed portion is inserted into the urethral cavity, the portion where the deformed portion faces the deformed portion of the urethral cavity is referred to as the urethra.
  • the expansion device according to any one of (1) to (16), wherein the expansion device is configured to expand in a direction in which the cavity and the vaginal cavity are separated from each other.
  • the procedure when a surgical procedure is performed on the living tissue between the vaginal cavity and the urethral cavity, the procedure can be performed easily and reliably.
  • the vaginal insertion member is inserted into the vaginal cavity, the urethral insertion member is inserted into the urethral cavity, and the vaginal side regulating means is used.
  • the positional relationship of the vaginal insertion member with respect to the living tissue can be regulated.
  • a part of living tissue between the urethral cavity and the vaginal cavity is peeled off, and the peeled part and the outside of the body are connected through a puncture hole formed by, for example, puncture. Communicate. Thereafter, an implant that supports the urethra is placed in the living tissue in the puncture hole.
  • FIG. 1 is a side view showing an operating state of the expansion device (first embodiment) of the present invention.
  • FIG. 2 is a view seen from the direction of arrow A in FIG.
  • FIG. 3 is a diagram viewed from the direction of arrow B in FIG.
  • FIG. 4 is a cross-sectional view taken along line CC in FIG.
  • FIG. 5 is an enlarged detail partial longitudinal sectional view of a region [D] surrounded by a one-dot chain line in FIG.
  • FIG. 6 is a cross-sectional view taken along the line EE in FIG.
  • FIG. 7 is a partial vertical cross-sectional view sequentially illustrating a method of using the expansion instrument shown in FIG. FIG.
  • FIG. 8 is a partial vertical cross-sectional view sequentially illustrating a method of using the expansion device shown in FIG.
  • FIG. 9 is a view showing a usage state of the expansion device (second embodiment) of the present invention.
  • FIG. 10 is a view seen from the direction of arrow G in FIG.
  • FIG. 11 is a side view showing a third embodiment of the expansion device of the present invention.
  • FIG. 12 is a diagram (a diagram illustrating an operating state of the clamping mechanism) viewed from the direction of arrow H in FIG. 11.
  • FIG. 13 shows the operating state of the clamping mechanism in the expansion device (fourth embodiment) of the present invention.
  • FIG. 14 is a partial longitudinal cross-sectional side view showing a fifth embodiment of the expansion device of the present invention.
  • FIG. 15 is a side view showing a sixth embodiment of the expansion device of the present invention.
  • FIG. 1 is a side view showing an operating state of an expansion device (first embodiment) according to the present invention
  • FIG. 2 is a view seen from the direction of arrow A in FIG. 1A
  • FIG. 3 is FIG. 4 is a cross-sectional view taken along the line CC in FIG. 1A
  • FIG. 5 is a region [D] surrounded by an alternate long and short dash line in FIG. 1A
  • 6 is an enlarged detail partial longitudinal sectional view
  • FIG. 6 is a sectional view taken along the line EE in FIG. 1 (a)
  • FIGS. 7 and 8 are partial longitudinal sectional views sequentially showing how to use the expansion device shown in FIG. FIG.
  • the lower side is referred to as the “tip” and the upper side is referred to as the “base end”, respectively.
  • 7 and 8 (the same applies to FIG. 9), the upper right side or upper left side is the “tip” and the lower left side or lower right side is the “base end” along the longitudinal direction of the vaginal insertion portion and urethral insertion portion.
  • the expansion device 1 shown in FIG. 1 is a medical device that is used by being inserted into the urethral cavity 100 and the vaginal cavity 200 when a female urinary incontinence is treated, that is, when an implant (in-vivo device) is embedded in a living body. It is.
  • the living tissue 300 includes a wall portion (urethral wall) that defines the urethral cavity 100, a wall portion (vagina wall) that defines the vaginal cavity 200, and the like.
  • the thickness of the living tissue 300 is generally about 5 to 20 mm in the case of an adult female, although there are individual differences.
  • the implant is a device that is embedded in the living tissue 300 and supports the urethra by pulling it away from the vaginal wall for the treatment of female urinary incontinence (see FIGS. 8 (f) and 8 (g)). ). As a result, the urethra can be supported, and urine leakage can be prevented.
  • the implant for example, a flexible long object can be used.
  • the implant is composed of a band 80. This band 80 is called a “sling”.
  • the size of the band 80 is not particularly limited and may be set as appropriate.
  • the width is preferably about 3 to 15 mm, and the thickness is preferably about 0.2 to 2 mm. .
  • constituent material of the belt 80 is not particularly limited.
  • various resin materials having biocompatibility can be used.
  • the implant is configured by a single band 80.
  • the present invention is not limited thereto, and the implant may be configured by a plurality of bands 80, for example.
  • the implant is not limited to the band 80, and other long objects having flexibility such as a thread and a string can be used.
  • a thread or string is used as the implant and the cross-sectional shape is circular, the diameter is preferably about 0.2 to 5 mm.
  • the dilator 1 has a longitudinal (long) vaginal insertion member 2 inserted into the vaginal cavity 200 and a longitudinal (long) inserted into the urethral cavity 100.
  • the urethral insertion member 3, the connecting means 4 for connecting the vaginal insertion member 2 and the urethral insertion member 3, the vaginal side regulation means 5 provided in the vaginal insertion member 2, and the urethra provided in the urethral insertion member 3 Side regulating means 6.
  • the configuration of each unit will be described.
  • the shape of the vaginal insertion member 2 is not particularly limited as long as it is a longitudinal shape, but as shown in FIGS. 1 to 4, in the present embodiment, it is plate-shaped. Then, the total length L 1 of the vaginal insertion member 2 is not particularly limited, for example, preferably in the range of 50 ⁇ 100 mm, and more preferably 60 ⁇ 90 mm.
  • the width w 1 of the vaginal insertion member 2 gradually decreases toward the distal direction.
  • the width w 1 (average) is not particularly limited, but is preferably, for example, 10 to 35 mm, and more preferably 15 to 30 mm.
  • the thickness t 1 of the vaginal insertion member 2 is also gradually reduced toward the distal end direction.
  • the thickness t 1 (average) is not particularly limited, but is preferably 2 to 10 mm, for example, and more preferably 4 to 8 mm.
  • the vaginal insertion member 2 has a window portion 24 constituted by a through-hole penetrating in the thickness direction.
  • the window 24 is a portion where the curved inner surface (the other surface) 22 side can be visually recognized from the curved outer surface (one surface) 23 side of the vaginal insertion member 2, and treatments such as puncture and incision are also possible. Part.
  • the tip 21 of the vaginal insertion member 2 is rounded. Therefore, when inserting the vaginal insertion member 2 into the vaginal cavity 200, it is possible to reliably prevent the living tissue 300 and the like from being damaged at the distal end 21 and improve the safety for the patient.
  • the vaginal insertion member 2 is curved in an arc shape in one direction, that is, in an arc shape, in a side view. Accordingly, when the vaginal insertion member 2 is inserted into the vaginal cavity 200 with the curved inner surface 22 facing the front side of the patient, the vaginal cavity 200 can be expanded and the surgical field can be directed to the front of the operator. It becomes easy to visually recognize through the window part 24, and can perform treatments such as puncture and incision.
  • the curvature of the vaginal insertion member 2 is not particularly limited because a suitable range varies depending on the patient's body position. For example, the curvature radius is preferably 60 to 240 mm. If transvaginal treatment such as puncture or incision to the vagina wall is not frequently performed, the vagina insertion member 2 may not be curved because it is not necessary to direct the surgical field to the front of the operator. A linear shape may be sufficient.
  • a urethral insertion member 3 is disposed on the curved inner side of the vaginal insertion member 2.
  • the shape of the urethral insertion member 3 is not particularly limited as long as it is a longitudinal shape. However, in this embodiment, the urethra insertion member 3 has a rod shape and is curved in the same direction as the vaginal insertion member 2.
  • the curvature of the urethral insertion member 3 is set with a small radius of curvature with respect to the curvature of the vaginal insertion member 2 so that the urethral insertion member 3 and the vaginal insertion member 2 have substantially parallel curves.
  • the urethral insertion member 3 Since the urethral insertion member 3 is curved in the same direction as the vaginal insertion member 2, an operation of inserting the urethral insertion member 3 into the urethral cavity 100 and an operation of inserting the vagina insertion member 2 into the vaginal cavity 200 are performed. It can be done easily in a lump. In addition, there is an advantage that damage to the urethral wall or the vagina wall due to friction and pressing can be minimized.
  • the urethral insertion member 3 has a constant width w 2 and thickness t 2 along the longitudinal direction.
  • the width w 2 is not particularly limited, but is preferably 2 to 7 mm, for example, and more preferably 3 to 6 mm.
  • the thickness t 2 is not particularly limited, but is preferably 2 to 7 mm, for example, and more preferably 2 to 5 mm. If the width w 2 of the urethral insertion member 3 is larger than the thickness t 2 , the urethral cavity 100 is deformed into a shape in which the urethra wall is greatly extended in the width direction. There is an advantage that the urethral insertion member 3 and the urethral wall are hardly separated when being separated from the vaginal insertion member 2. Therefore, it is preferable that the width w 2 of the urethral insertion member 3 is larger than the thickness t 2 within a range where insertion into the urethral cavity 100 is not hindered.
  • the tip 33 of the urethral insertion member 3 is rounded. Therefore, when inserting the urethral insertion member 3 into the urethral cavity 100, it is possible to reliably prevent the living tissue 300 and the like from being damaged at the tip 33, and to improve the safety for the patient.
  • the connecting means 4 connects the base end portions of the vaginal insertion member 2 and the urethral insertion member 3 so that these members can approach and separate from each other.
  • the connecting means 4 includes a pair of small pieces 42 formed on the curved inner surface 22 of the vaginal insertion member 2 so as to protrude toward the urethral insertion member 3, and a curved outer side of the urethral insertion member 3.
  • the surface 34 has one elongated protrusion 43 formed to protrude toward the vaginal insertion member 2 side. And the protrusion part 43 will be inserted in the clearance gap 41 between a pair of small pieces 42, and the said protrusion part 43 will be supported so that sliding to the longitudinal direction is possible.
  • the protrusion 43 moves with respect to the gap 41, that is, protrudes and retracts, so that the vaginal insertion member 2 and the urethral insertion member 3 can approach and separate from each other. Thereby, the distance D between the curved inner surface 22 of the vaginal insertion member 2 and the curved outer surface 34 of the urethral insertion member 3 is changed. Therefore, in the connecting means 4, the pair of small pieces 42 and the protrusions 43 also function as adjusting means for adjusting the distance D.
  • the adjusting means appropriately adjusts the vaginal insertion member 2 and the urethral insertion member. The distance D between 3 can be adjusted to suit the patient.
  • the adjustment range of the distance D is preferably 5 to 35 mm, for example, so as to match the thickness of the living tissue 300 and the expanded portion 301 (see FIG. 7).
  • the protrusion 43 is provided with a scale 44 indicating the distance D. Thereby, distance D can be grasped correctly.
  • the expansion device 1 has a bolt (male thread) 45. As shown in FIG. 6, the bolt 45 is screwed into a female screw 421 formed on one small piece 42 of the pair of small pieces 42.
  • the distance D becomes variable.
  • the connecting means 4 includes the bolt (male screw) 45 and the female screw 421 formed on the small piece 42, and has a lock mechanism that maintains the distance D temporarily constant. .
  • each component which comprises the connection means 4, the vagina insertion member 2, and the urethral insertion member 3 does not specifically limit as each component which comprises the connection means 4, the vagina insertion member 2, and the urethral insertion member 3,
  • various metal materials such as aluminum, aluminum alloy, stainless steel, or various A resin material can be used.
  • the vaginal side regulating means 5 regulates the positional relationship of the vaginal insertion member 2 inserted into the vaginal cavity 200 with respect to the living tissue 300.
  • the vaginal side regulating means 5 has an internal space 51 formed inside the vaginal insertion member 2 and a curved inner surface 22 of the vaginal insertion member 2 (facing the urethral insertion member 3 side).
  • the internal space 51 is partitioned into a plurality of rooms (rooms 51 a, 51 b, 51 c) via a wall portion 511 provided in the internal space 51.
  • the room 51a is disposed on the left side in FIG. 4
  • the room 51c is disposed on the right side in FIG. 4
  • the room 51b is disposed between the room 51a and the room 51c and on the upper side in FIG. ing.
  • the plurality of suction ports 52 are arranged in a matrix in the surface direction of the curved inner surface 22 of the vaginal insertion member 2 so as to surround the window portion 24.
  • these suction ports 52 include a suction port communicating with the room 51a (hereinafter referred to as “suction port 52a”) and a suction port communicating with the room 51b (hereinafter referred to as this suction port).
  • suction port 52b There is a suction port referred to as “suction port 52b”) and a suction port communicating with the room 51c (hereinafter, this suction port is referred to as “suction port 52c”).
  • Each of the ports 53a, 53b, and 53c is formed of a tubular body.
  • the port 53a communicates with the room 51a
  • the port 53b communicates with the room 51b
  • the port 53c communicates with the room 51c.
  • the ports 53a, 53b, and 53c are connected to a pump 20 as a suction means that can suck three chambers 51a, 51b, and 51c (internal space 51) independently of each other. ing.
  • the pump 20 can be operated in this connected state.
  • the respective suction ports 52, respectively, is generated suction force F 1.
  • the living tissue 300 can be drawn so as to be in close contact with the curved inner surface 22 of the vaginal insertion member 2.
  • the positional relationship of the curved inner surface 22 with respect to the living tissue 300 is reliably regulated in the vaginal insertion member 2 inserted into the vaginal cavity 200, that is, the longitudinal direction, the width direction, and the thickness direction of the vaginal insertion member 2 Therefore, it is possible to reliably prevent deviation from the restricted position.
  • the pump 20 when the pump 20 is operated, for example, when some of the suction ports 52a are separated from the living tissue 300 due to unexpected movement of the patient, the separated suction ports 52a are separated.
  • room 51a through it communicates with the atmosphere, i.e., the open air, air-tightness is undermined, the suction force F 1 on each suction port 52a may deteriorate respectively.
  • the expansion device 1 since the rooms 51a, 51b, and 51c are independent of each other by the wall portion 511, even if the air in the room 51a leaks, the remaining rooms 51b and 51c are airtight. Yes.
  • the suction force F 1 on each suction port 52b communicating with the room 51b, the suction force F 1 on each suction port 52c which communicates with the room 51c, respectively, can be reliably prevented from being lowered, thus, vaginal
  • the positional relationship of the insertion member 2 with respect to the living tissue 300 can be sufficiently restricted.
  • the number of compartments in the internal space 51 is three in the present embodiment, but is not limited to this, and may be one, two, four or more, for example.
  • the number of the suction ports 52 communicating with each room is plural in the present embodiment, but is not limited thereto, and may be one, for example.
  • the number of ports connected to the pump 20 is three in this embodiment, but is not limited thereto, and may be one, two, four or more, for example.
  • the urethral side regulating means 6 regulates the positional relationship of the urethral insertion member 3 inserted into the urethral cavity 100 with respect to the living tissue 300.
  • the urethral side regulating means 6 is formed in the expandable / deflatable balloon 61 installed at the distal end portion of the urethral insertion member 3 and is formed in the urethral insertion member 3 to expand / deflate the balloon 61.
  • a lumen 62 serving as a flow path through which the working fluid passes, and a port 63 that projects from the curved inner surface 35 of the urethral insertion member 3 and communicates with the lumen 62 are provided.
  • the balloon 61 is configured by a membrane formed in a cylindrical shape, and the base end portion and the distal end portion thereof are installed by being airtightly fixed to the outer peripheral surface of the urethral insertion member 3.
  • the lumen 62 has a distal end opening in the balloon 61.
  • the balloon 61 is inserted into the patient's bladder 400 when the expansion device 1 is used, and is caught on the bladder neck 401 in an expanded state.
  • the longitudinal position of the urethral insertion member 3 can be regulated with respect to the living tissue 300, and thus the urethral insertion member 3 can be reliably prevented from being unintentionally removed from the urethral cavity 100. Can do.
  • the method for fixing the balloon 61 to the urethral insertion member 3 is not particularly limited.
  • a method using fusion thermal fusion, high-frequency fusion, ultrasonic fusion, etc.
  • adhesion adhesion using an adhesive or a solvent.
  • the constituent material of the balloon 61 is not particularly limited.
  • polyester resin such as polyethylene terephthalate, polyethylene naphthalate, polybutylene terephthalate, polybutylene naphthalate or the like, polyester elastomer containing the same, olefin resin such as polyethylene and polypropylene, or the like
  • olefin resin such as polyethylene and polypropylene
  • polyamide resins such as nylon 11, nylon 12, nylon 610 or the like
  • polyamide elastomers containing the same polyurethane resins
  • ethylene-vinyl acetate copolymers Alternatively, materials obtained by subjecting them to crosslinking treatment, or materials such as polymer blends and polymer alloys containing at least one of these can be used.
  • the lumen 62 is formed so as to penetrate the urethral insertion member 3.
  • the distal end portion of the lumen 62 is opened in the balloon 61 as described above, and the proximal end portion is opened on the curved inner surface 35 of the urethral insertion member 3.
  • the port 63 is formed of a tubular body and communicates with the lumen 62.
  • a balloon expansion device such as a syringe (not shown) can be connected to the port 63. Then, the balloon expanding device is operated in the connected state, and the working fluid supplied from the balloon expanding device is sent into the balloon 61 through the lumen 62, or the working fluid is extracted, and the balloon 61 is expanded and contracted.
  • a working fluid for balloon expansion for example, a liquid such as physiological saline or a gas such as air can be used.
  • a valve body like a balloon expansion port of a commercially available urinary catheter (foley catheter), a valve body (see FIG. 5) that opens a flow path only when a balloon expansion device such as a syringe is connected to the port 63. (Not shown) is preferably provided.
  • the expansion device 1 is prepared. At this time, in the expansion device 1, the balloon 61 is not expanded yet and is contracted. A syringe (not shown) preliminarily filled with physiological saline is also prepared. The physiological saline is used as a working fluid that operates the balloon 61.
  • the expansion device 1 is attached to the patient. That is, the vaginal insertion member 2 of the dilator 1 is inserted into the vaginal cavity 200 and the urethral insertion member 3 is inserted into the urethral cavity 100. This insertion is performed until the balloon 61 is located in the bladder 400.
  • the connecting means 4 is operated as necessary to adjust the distance D between the vaginal insertion member 2 and the urethral insertion member 3.
  • the bolt 45 is rotated in a loosening direction to bring the vaginal insertion member 2 and the urethral insertion member 3 closer to or away from each other.
  • the distance D is adjusted so that the vaginal insertion member 2 can be inserted into the vaginal cavity 200 and the urethral insertion member 3 can also be inserted into the urethral cavity 100.
  • the bolt 45 is rotated in the tightening direction, and the distance D is temporarily maintained.
  • the bolt 45 is rotated in advance in the loosening direction, and the vaginal insertion member 2 and the urethral insertion member 3 are separately inserted into the vaginal cavity 200 and the urethral cavity 100, and then the protrusion 43 is connected to a pair of small pieces. It is also possible to connect to 42.
  • the syringe is connected to a port 63 provided in the urethral insertion member 3, and the syringe is operated to supply physiological saline into the lumen 62.
  • the balloon 61 is expanded and engaged with the bladder neck 401 of the bladder 400.
  • the longitudinal position of the urethral insertion member 3 with respect to the urethral cavity 100 is restricted, and thus the urethral insertion member 3 is prevented from being unintentionally removed from the urethral cavity 100.
  • the ports 53 a to 53 c provided in the vaginal insertion member 2 are connected to the pump 20. At this time, the pump 20 is still stopped.
  • the pump 20 is operated. Accordingly, it occurs each attraction force F 1 on each suction port 52 formed in the vaginal insertion member 2 as described above, the positional relation relative to the living tissue 300 of the vaginal insertion member 2 is reliably restricted.
  • the vaginal insertion member 2 is gradually separated from the urethral insertion member 3. At this time, the vaginal insertion member 2 is reliably prevented from being separated from the living tissue 300 by the suction force F 1 (vaginal side regulating means 5).
  • the living tissue 300 is forcibly pulled (corrected) in the operation direction (separation direction).
  • the living tissue 300 becomes the expanded portion 301 that is expanded in a direction in which the urethral cavity 100 and the vaginal cavity 200 are separated from each other, that is, becomes thick.
  • the band 80 is passed through the puncture hole 302 using, for example, a guide wire (not shown).
  • the band 80 is in a state in which both end portions thereof protrude from the puncture hole 302 to the outside of the body with the urethra wall (expansion portion 301) hooked.
  • the expansion device 1 is removed from the patient. That is, the vaginal insertion member 2 of the expansion device 1 is removed from the vaginal cavity 200 and the urethral insertion member 3 is removed from the urethral cavity 100. During this extraction operation, the operation of the pump 20 is stopped and the balloon 61 is deflated. When the expansion device 1 is removed from the patient, the living tissue 300 is restored to the original state (shape), that is, the expanded portion 301 is eliminated.
  • expansion instrument 1 demonstrated in this embodiment the case where it is used when implanting the implantable implant for the treatment of female urinary incontinence in a living body, it is not limited to this, For example, a pelvic organ It is also used for other purposes such as treatment of diseases of pelvic organs including prolapse.
  • FIG. 9 is a view showing a use state of the expansion device (second embodiment) of the present invention
  • FIG. 10 is a view seen from the direction of arrow G in FIG.
  • This embodiment is the same as the first embodiment except that the configuration of the urethral side regulating means is different.
  • the urethral side regulating means 6 ⁇ / b> A of the expansion device 1 is formed inside the urethral insertion member 3 independently of the lumen 62 and becomes a flow path through which air passes.
  • a plurality of (four in this embodiment) auxiliary suction ports 65 that are formed to open to the lumen 64 and the curved outer surface 34 of the urethral insertion member 3 (surface facing the vaginal insertion member 2 side) and communicate with the lumen 64.
  • a port 66 that projects from the urethral insertion member 3 and communicates with the lumen 64.
  • the lumen 64 is formed so as to penetrate the urethral insertion member 3.
  • Each auxiliary suction port 65 is arranged along the direction in which the lumen 64 is formed (longitudinal direction of the urethral insertion member 3).
  • the port 66 is formed of a tubular body and communicates with the lumen 64.
  • the pump 20 is connected to the port 66.
  • the pump 20 can be operated to suck the inside of the lumen 64.
  • the auxiliary suction ports 65 respectively, is generated suction force F 2.
  • the living tissue 300 can be drawn so as to be in close contact with the curved outer surface 34 of the urethral insertion member 3.
  • the positional relationship of the curved outer surface 34 with respect to the living tissue 300 is reliably regulated in the urethral insertion member 3 inserted into the urethral cavity 100, that is, the longitudinal direction, the width direction, and the thickness direction of the urethral insertion member 3. Therefore, it is possible to reliably prevent deviation from the regulated position.
  • the vaginal insertion member 2 is separated from the urethra insertion member 3 while the vaginal side restriction means 5 is operated, for example, if the separation speed is too fast or the separation distance is too long, the urethral cavity 100 of the living tissue 300 is. 9 is also pulled in that direction (see the portion indicated by the two-dot chain line in FIG. 9), and as a result, the expanded portion 301 is unlikely to be formed in the living tissue 300.
  • the unintentional deformation of the living tissue 300 due to excessive tension on the living tissue 300 is reliably prevented or restricted by the suction force F 2 at each auxiliary suction port 65. Can do. Thereby, the extended part 301 can be formed more reliably.
  • auxiliary suction ports 65 is four in the present embodiment, but is not limited thereto, and may be one, two, three, five or more, for example.
  • FIG. 11 is a side view showing a third embodiment of the expansion device of the present invention
  • FIG. 12 is a view (a view showing an operating state of the clamping mechanism) seen from the direction of arrow H in FIG.
  • This embodiment is the same as the first embodiment except that the configuration of the vaginal side regulating means is different.
  • the vaginal side regulating means 5A has a plurality (two in this embodiment) having a pair of clamping pieces that clamp (pick) the living tissue 300 from the vagina cavity 200 side. ) Clamping mechanism (clamping tool) 54.
  • Each clamping mechanism 54 is mounted by being inserted into a mounting portion 26 constituted by a through hole formed in the vagina insertion member 2, and is disposed on the vagina insertion member 2 at intervals along the longitudinal direction thereof. Since each clamping mechanism 54 has the same configuration, the clamping mechanism 54 disposed on the base end side will be described below representatively.
  • the sandwiching mechanism 54 includes a pair of sandwiching pieces 55 that sandwich the living tissue 300, and a compression coil spring 56 as a biasing member (biasing unit) that collectively biases each sandwiching piece 55. have.
  • Each of the sandwiching pieces 55 is formed of a long body, and the vicinity of the central portion in the longitudinal direction is connected to be rotatable. And the one end part 551 by the side of the urethra insertion member 3 of each clamping piece 55 has faced the direction which mutually opposes. Thereby, each clamping piece 55 can approach one end part 551 (refer Fig.12 (a)) and separate (refer FIG.12 (b)), and the clamping force which clamps the biological tissue 300 when it approaches. Is obtained.
  • each pinching piece 55 is formed with a guide pin 553 so as to project, and the guide rail 27 provided on the vaginal insertion member 2 can be slid.
  • the holding mechanism 54 can stably approach / separate each holding piece 55 in a state of being attached to the attachment portion 26.
  • the compression coil spring 56 is disposed between the other end portions 552 opposite to the one end portion 551 of each sandwiching piece 55.
  • each clamping piece 55 can be urged in the direction of the arrow in which the clamping force is released, and one end portions 551 of each clamping piece 55 are opened. It becomes a state.
  • FIG.12 (b) when the other end part 552 of each clamping piece 55 is pressed operation against the urging
  • a lock mechanism (not shown) similar to that used in general surgical forceps.
  • the living tissue 300 is clamped from the vaginal cavity 200 side by operating each clamping piece 55 in a state where the vaginal insertion member 2 is inserted into the vaginal cavity 200. be able to. Thereby, the biological tissue 300 can be attracted to the vaginal insertion member 2 and the positional relationship of the vaginal insertion member 2 with respect to the biological tissue 300 can be regulated.
  • the living tissue 300 is forcibly pulled toward the separation direction. Thereby, the living tissue 300 becomes the expansion part 301, and when performing a surgical treatment (separation operation and puncture operation) on the expansion part 301, the treatment can be easily and reliably performed.
  • positioning of the clamping mechanism 54 is two in this embodiment, it is not limited to this, For example, one or three or more may be sufficient.
  • FIG. 13 is a diagram showing an operating state of the clamping mechanism in the expansion device (fourth embodiment) of the present invention.
  • the clamping mechanism 54 of the vaginal side regulating means 5B has a “C” shape as a biasing member that biases each clamping piece 55 in the direction in which the clamping force is generated.
  • a spring 57 having a ring shape is provided.
  • the spring 57 has one end 571 engaged with one of the two holding pieces 55 and the other end 572 engaged with the other holding piece 55 of the two holding pieces 55.
  • the living tissue 300 is forcibly pulled toward the separation direction. Thereby, the living tissue 300 becomes the expansion part 301, and when performing a surgical treatment (separation operation and puncture operation) on the expansion part 301, the treatment can be easily and reliably performed.
  • FIG. 14 is a partial longitudinal cross-sectional side view showing a fifth embodiment of the expansion device of the present invention.
  • This embodiment is the same as the first embodiment except that the configuration of the vaginal side regulating means is different.
  • each suction port 52 has a protruding portion 521.
  • the protruding portion 521 protrudes from the curved inner surface 22 of the vaginal insertion member 2 toward the urethral insertion member 3 side (left side in FIG. 4), and has a ring shape when viewed from the curved inner surface 22 side. It is.
  • the projecting portion 521 improves the adhesion with the living tissue 300 (vagina wall), and as a result, Airtightness in the internal space 51 can be secured more stably.
  • each suction port 52 has the protrusion part 521 in the structure of illustration, respectively, it is not limited to this, The one part suction hole 52 of these suction holes 52 is the protrusion part 521. It may be omitted.
  • FIG. 15 is a side view showing a sixth embodiment of the expansion device of the present invention.
  • This embodiment is the same as the first embodiment except that the shape of the urethral insertion member is different.
  • the urethral insertion member 3 has a deformed portion 36 whose part, that is, in the middle of the longitudinal direction, is deformed into a wave shape in a side view.
  • the portion of the urethral cavity 100 that faces the deformed portion 36 can be expanded in the direction in which the urethral cavity 100 and the vaginal cavity 200 are separated. Thereby, the expansion part 301 is more reliably formed in the living tissue 300.
  • each part which comprises an expansion tool is a thing of arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.
  • expansion device of the present invention may be a combination of any two or more configurations (features) of the above embodiments.
  • the expansion device of the present invention includes a longitudinal vaginal insertion member inserted into the vaginal cavity among the vaginal cavity and the urethral cavity adjacent to each other through a living tissue, and a longitudinal shape inserted into the urethral cavity.
  • Vaginal regulation means for regulating the positional relationship with respect to the living tissue, inserting the vaginal insertion member into the vaginal cavity, inserting the urethral insertion member into the urethral cavity, and operating the vaginal regulation means
  • the vagina insertion member is separated from the urethral insertion member, so that the living tissue is expanded in the separation direction. Therefore, when performing a surgical procedure on the living tissue between the vagina

Abstract

L'instrument d'extension (1) de l'invention est équipé : d'un élément pour insertion vaginale (2) de forme longitudinale s'insérant à l'intérieur d'une cavité vaginale (200), considérant la cavité vaginale (200) et une cavité urétrale (100) adjacentes l'une à l'autre avec des tissus vivants (300) pour intermédiaire; d'un élément pour insertion urétrale (3) de forme longitudinale s'insérant à l'intérieur de la cavité urétrale (100); d'un moyen de raccord (4) raccordant l'élément pour insertion vaginale (2) et l'élément pour insertion urétrale (3) de manière à pouvoir les rapprocher / les éloigner l'un de l'autre; et d'un moyen de régulation côté vagin (5) qui est agencé sur l'élément pour insertion vaginale (2), et qui régule une relation de positions de l'élément pour insertion vaginale (2) inséré dans la cavité vaginale (200) par rapport aux tissus vivants (300). L'instrument d'extension (1) est configuré de sorte à ce que dans un état dans lequel l'élément pour insertion vaginale (2) est inséré à l'intérieur de la cavité vaginale (200), l'élément pour insertion urétrale (3) est inséré à l'intérieur de la cavité urétrale (100), et ladite relation de positions est régulée sous l'action du moyen de régulation côté vagin (5), l'élément pour insertion vaginale (2) est éloigné de l'élément pour insertion urétrale (3), élargissant ainsi les tissus vivants (300) dans la direction de cet éloignement.
PCT/JP2012/069684 2011-11-22 2012-08-02 Instrument d'extension WO2013077031A1 (fr)

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JP2013545816A JP6000975B2 (ja) 2011-11-22 2012-08-02 拡張器具
DE112012004850.4T DE112012004850T5 (de) 2011-11-22 2012-08-02 Dehnungsinstrument
US14/283,834 US9642636B2 (en) 2011-11-22 2014-05-21 Expansion instrument

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JP2011255412 2011-11-22
JP2011-255412 2011-11-22

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US14/283,834 Continuation US9642636B2 (en) 2011-11-22 2014-05-21 Expansion instrument

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WO (1) WO2013077031A1 (fr)

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Publication number Priority date Publication date Assignee Title
WO2015041080A1 (fr) * 2013-09-21 2015-03-26 テルモ株式会社 Outil d'insertion dans un corps vivant et procédé d'aspiration
WO2015093239A1 (fr) * 2013-12-18 2015-06-25 テルモ株式会社 Applicateur vaginal et procédé d'aspiration
US20150190163A1 (en) * 2014-01-06 2015-07-09 Boston Scientific Scimed, Inc. Medical devices for tissue extraction and related methods

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Publication number Priority date Publication date Assignee Title
WO2014162429A1 (fr) * 2013-04-01 2014-10-09 テルモ株式会社 Dispositif d'insertion et dispositif de ponction
WO2015041142A1 (fr) * 2013-09-20 2015-03-26 テルモ株式会社 Outil médical et procédé de ponction

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JPH09248306A (ja) * 1991-12-03 1997-09-22 Beshika Medical Inc 医療機器を支持して位置決めするための支持構造
JP2001511686A (ja) * 1997-02-13 2001-08-14 ボストン サイエンティフィック リミテッド 侵襲性を最小にした骨盤手術のための方法および装置

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CA2478448C (fr) 2002-03-07 2011-06-21 Ams Research Corporation Articles chirurgicaux trans-obturateurs et procedes associes
US20080171905A1 (en) * 2007-01-17 2008-07-17 Ams Research Corporation Transvaginal Delivery of Bulking Masses Adjacent the Urethra to Alleviate Female Incontinence

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Publication number Priority date Publication date Assignee Title
JPH09248306A (ja) * 1991-12-03 1997-09-22 Beshika Medical Inc 医療機器を支持して位置決めするための支持構造
JP2001511686A (ja) * 1997-02-13 2001-08-14 ボストン サイエンティフィック リミテッド 侵襲性を最小にした骨盤手術のための方法および装置

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015041080A1 (fr) * 2013-09-21 2015-03-26 テルモ株式会社 Outil d'insertion dans un corps vivant et procédé d'aspiration
WO2015093239A1 (fr) * 2013-12-18 2015-06-25 テルモ株式会社 Applicateur vaginal et procédé d'aspiration
US20150190163A1 (en) * 2014-01-06 2015-07-09 Boston Scientific Scimed, Inc. Medical devices for tissue extraction and related methods

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US20140350330A1 (en) 2014-11-27
US9642636B2 (en) 2017-05-09
JPWO2013077031A1 (ja) 2015-04-27
JP6000975B2 (ja) 2016-10-05
DE112012004850T5 (de) 2014-09-04

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